Clean Patient Tracker

Data managers need to provide complete and clean patient data throughout the lifetime of a study. Today study teams use Excel or custom solutions to pull data together then manually mark subjects that are deemed clean and ready for lock. This process is time consuming, limited and prone to errors. With the Clean Patient Tracker, you can track the cleanliness of Subjects and take direct action on data management cleaning activities.

CDB includes a subject-centric page, the Clean Patient Tracker, for data managers to review the cleanliness of each patient. You can filter the grid by cleaning activities and study meta data such as site, country, cohort etc. You are able to quickly take action on a subject such as reviewing and closing answered queries.

Accessing the Clean Patient Tracker

The Clean Patient Tracker is under the Subjects tab in CDB.

You can access this page from either the Study menu () on the Studies page or from the Navigation Drawer () after you’ve selected a Study.

About the Clean Status

There is a Clean column in the listing, which can show true, to indicate a clean subject, and false. A Subject enters the Clean status when the following conditions are met:

• All Queries are in the Closed status.
• All runs for Checks are completed. This means that all checks ran successfully, and there were no invalid checks (for example, due to an invalid CQL statement).
• All required SDV is completed.
• All terms are coded.

Viewing Subject Information

Columns

The Clean Patient Tracker includes the following columns:

Column	Description
Subject Name	The Subject ID (Name) of the Subject. Clicking the value in this column opens the subject’s Casebook in the Review tab of Vault EDC.
Subject Status	The Status of the Subject
Country	The Study Country of the Subject
Arm	The Arm the subject is assigned to. If there is no assigned Arm, this column is blank.
Cohort	The Cohort the subject is assigned to. If there is no assigned Cohort, this column is blank.
Site	The Site number assigned to the Subject
Latest Event	The latest Event (Visit) for the Subject
Overdue Events	The number of Events in the Overdue status for the Subject (scheduled, incomplete Events where the Planned Date is earlier than the current date, and the Event is NULL and not entered)
Overdue Forms	The number of forms overdue for a given subject is determined when the following conditions are met: the overdue form date is earlier than today, the form is not submitted, and the form is not marked as Intentionally Left Blank (ILB). Blank repeating forms and third-party forms are excluded from the overdue count. Overdue forms are not part of the subject’s clean score calculation.
Incomplete Reviews by Subject	The total count (number) of subjects with incomplete Review Listings. Incomplete Reviews are totaled by adding the following: All Invalid Review Listings and Review Listings containing the subject where at least one row associated with the subject is Unreviewed, In-Progress or No Review. Incomplete Review counts are factored into the definition of a clean patient. To deem a subject clean, all reviews must be complete. This column is calculated from review enabled listings only, where the review listing must contain the subject name and site number (or site name).
Incomplete SDV	The total count (number) of Forms and Event Dates that are SDV Required and incomplete
In-Progress Log Forms	The count of In-Progress and/or In-Edit log forms for each subject. Log forms are not part of the scheduled data collection and are not considered overdue. They also do not contain defined Event Dates. Users should be attentive to any Serious Adverse Events still in-progress.
Open Queries	The total count (number) of Queries in the Open status. This includes both EDC and third-party queries. Clicking the link in this column opens a query listing of these queries in the Queries page of CDB so that you can take action on those open queries.
Answered Queries	The total count (number) of Queries in the Answered status. This includes both EDC and third-party queries. Clicking the link in this column opens a query listing of these queries in the Queries page of CDB so that you can take action on answered queries.
Uncoded Terms	The total count (number) of coding terms where the Coding Status is Open, Uncoded, Rejected, Noncurrent, or Updated.
Incomplete Checks	This column shows the number of Checks that didn’t run as scheduled for the Study. If the Study has at least one Check that is scheduled to run hourly and didn’t run as scheduled, this column shows (for every subject) the total number of checks that need attention. Reasons for incomplete checks include a missing third party source, a missing third party data package, or a study design change. Once the Check is modified to accommodate the change and runs successfully, this column updates accordingly. See Automating Queries with Checks for additional details.
Clean	This column shows “true” when the subject is clean. When the subject isn’t clean, this column shows “false”. A subject is considered clean when there are zero incomplete SDVs, open queries, answered queries, uncoded terms, and incomplete checks. If all these counts are zero, the subject is deemed clean. Overdue events are not included in this determination.
Summary	This column shows signed, frozen, and locked statuses.

Filter by Site

You can filter the list of subjects by Site. The filter shows a count of the Subjects assigned to a Site. In the Filters panel, click a Site to show only Subjects assigned to that Site.

Click Close () to close the Filters panel. Click Filter to reopen it.

Sort & Filter the Subjects Grid

You can easily sort and filter subjects using the Sort & Filter menu. To open the Sort & Filter menu, click the column header for the column you want to sort by or apply a filter to.

If a column already has a sort or filter applied, Workbench shows the Sort icon ( for ascending or for descending) and the Filter icon (filter_list). You can click these in the Column Header to edit the sort or filter. You can also sort and filter columns that don’t already have a sort and filter.

How to Sort

You can sort by a single column using the Sort & Filter menu.

To sort by a column:

1. Locate the column you want to sort by in the datasheet.
2. If the column doesn’t already have a sort or filter applied, hover over the Column Header to show the Filter icon (filter_list).
3. Click the Filter icon (filter_list). This opens the Sort & Filter menu.
4. Under Sort by, select Ascending (A to Z) or Descending (Z-A) for a sort order.
5. Click OK. Workbench sorts the datasheet by the column values in the chosen sort order. Workbench shows a Sort icon ( for ascending or for descending) in the column header.

How to Reset a Column’s Sort Order

To reset (remove) the sort and return the listing to the default order, open the Sort & Filter menu and click Reset.

How to Filter by a Column

You can also filter your list of subjects using the Sort & Filter menu. You can select a comparison operator and, if required, a value to filter by, and use them as a filter.

To filter your listing with a conditional filter:

1. Locate the column you want to filter by in the datasheet.
2. Hover over the Column Header to show the Filter icon (filter_list).
3. Click the Filter icon (filter_list). This opens the Sort & Filter menu.
4. Under Condition, select an Operator. Workbench uses the entered Value and chosen Operator to compare the values within the column. There are different operators available for different column data types.

5. If required, enter a Value compare values against. Note that you can only use a static value and not a function. For dates, use YYYY-MM-DD.

6. Click OK.

The following comparison operators are available for filtering. Note that the available operators are limited by a column’s data type.

• AND: Logical AND
• OR: Logical OR
• =: Equals
• !=: Does not equal
• >: Greater than
• <: Less than
• >=: Greater than or equal to
• <=: Less than or equal to
• IS: Tests a value against a boolean condition
• IS NOT: Tests a value against a boolean condition
• IS NULL: Tests a value against a NULL
• IS NOT NULL: Tests a value against a NULL
• IN(): Check whether a value is within a defined set of values
• BETWEEN...AND...: Check whether a value is within a range of values
• CONTAINS: Check whether a value is contained within the value
• DOES NOT CONTAIN: Checks whether a value is not contained within the value

Download Progress Reports

You can download Subject, Event, and Form progress reports from the Clean Patient Tracker. Reports are in CSV format.

For the Subject progress report, any filters applied in the UI will also be applied to the CSV output.

To download a Subject report:

1. Navigate to the Clean Patient Tracker.

2. From the Subjects menu (), select Download Subject Report.

3. Save the CSV file.

To download Form and Event reports:

1. On the same page, click Generate Reports at the top-right corner of the screen.

2. Refresh the page to see Reports as the new option.
3. Click Reports to download the ZIP file.

The ZIP file contains both the Event and Form progress reports. Reports are generated once per hour. A report can only be generated if one hasn’t been generated in the past hour.

Form Progress Reports

Form progress reports are available for download by users with restricted data access, such as Vault Owners and Lead Data Managers.